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Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by MediGus Ltd.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
MediGus Ltd
ClinicalTrials.gov Identifier:
NCT00734747
First received: August 13, 2008
Last updated: December 5, 2010
Last verified: December 2010
History of Changes
  Purpose

The study is designed to test the safety and efficacy of the Medigus SRS endoscopic stapling system for the treatment of GERD.

The system allows the operator to staple the stomach to the esophagus,in order to restore the gastroesophageal flap valve. The effect of the stapling is similar to a common operation for GERD (partial fundoplication) but is done through the mouth, and incision into the abdomen is not needed.

The hypothesis of the study is that the treatment will be effective in improving GERD related quality of life by 50% or more in the majority of the subjects, and that the procedure will be as safe as surgery.


Condition Intervention Phase
Gastroesophageal Reflux Disease (GERD)
 Device: MediGus SRS endoscopic stapling system
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Medigus SRS Endoscopic Stapling System for the Treatment of Gastro-Esophageal Reflux Disease (GERD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by MediGus Ltd:

Primary Outcome Measures:
  • Improved GERD Health Related Quality of life (GERD-HRQL - Velanovitch) scores by 50% or more [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Procedure-related adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reduction of acid exposure (%time pH<4) on off PPI ambulatory 24h acid exposure test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Reduction of Proton Pump inhibitor use, as reported by subject [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • A grade I or II gastroesophageal flap valve according to the Hill classification (by endoscopy) [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • In subjects with hiatal hernia, maintenance of reduction [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: May 2008
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: MediGus SRS endoscopic stapling system
    The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location.
    Other Names:
    • endoluminal treatment of GERD
    • Incisionless treatment of GERD
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of GERD related symptoms for at least 2 years.
  • Recent objective evidence of GERD, demonstrated by a 24h pH acid exposure test.
  • History of daily intake of PPIs for at least 6 months, with significant relief of symptoms (i.e., difference in GERD HRQL scores on and off PPI > =6).
  • GERD-HRQL ≥20 off of PPI's

Exclusion Criteria:

  • Hiatal hernia > 3 cm or a paraesophageal hernia
  • Barrett's esophagus or grade IV esophagitis
  • Esophageal stricture, ring or web causing symptoms of dysphagia
  • Grade I Flap valve according Hill's classification
  • History of co-morbidity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734747

Locations
United States, California
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
UC San Diego
San Diego, California, United States, 92103-8401
United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Columbia University
New York, New York, United States, 10027-6900
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Austria
Akh Vienna City General Hospital
Vienna, Austria, A-1090
Sponsors and Collaborators
MediGus Ltd
Investigators
Study Director: Aviel Roy-Shapira, M.D. MediGus Ltd
  More Information

No publications provided

Responsible Party: Aviel Roy-Shapira, M.D. Chief Medical Officer, MediGus Ltd.
ClinicalTrials.gov Identifier: NCT00734747     History of Changes
Other Study ID Numbers: DCLP09002
Study First Received: August 13, 2008
Last Updated: December 5, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by MediGus Ltd:
GERD
Gastroesophageal Reflux
Fundoplication
Endoluminal
Gastroesophageal Flap Valve

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013